MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 227 mg/dl.The customer's expected fasting blood glucose test result range is 90 - 152 mg/dl.The customer stated that truemetrix meter is reading up to 50 mg/dl higher than both his onetouch and contour meter.The customer stated that he did not know the results the contour and onetouch were giving but he knows that the two were within 2-3 mg/dl of each other when the truemetrix was about 50 mg/dl higher.The customer stated he no longer has strips for his other meters so he will not be comparing meters.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2016, a back to back blood test was not performed by the customer.The product is stored in the dining room near the kitchen.The test strip lot manufacturer's expiration date is 07/28/2017 and open vial date at time of call is a little over a month ago.The meter memory was reviewed for previous test result history: 222mg/dl (b)(6) 2016 01:13 pm fasting: no; 154mg/dl (b)(6) 2016 05:35 pm fasting: yes; 255mg/dl (b)(6) 2016 08:13 am fasting: no; 227mg/dl (b)(6) 2016 07:56 am fasting: yes; 268mg/dl (b)(6) 2016 06:54 pm fasting: no.Memory concerns: 227 268 255 222mg/dl.
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user's test strip had poor storage.(b)(4).Correction - most likely underlying root cause of malfunction: user's test strip had poor storage (previously: user had an inaccurate reference).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 227 mg/dl.The customer's expected fasting blood glucose test result range is 90 - 152 mg/dl.The customer stated that truemetrix meter is reading up to 50 mg/dl higher than both his onetouch and contour meter.The customer stated that he did not know the results the contour and onetouch were giving but he knows that the two were within 2-3 mg/dl of each other when the truemetrix was about 50 mg/dl higher.The customer stated he no longer has strips for his other meters so he will not be comparing meters.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on 11/29/2017, a back to back blood test was not performed by the customer.The product is stored in the dining room near the kitchen.The test strip lot manufacturer's expiration date is 07/28/2017 and open vial date at time of call is a little over a month ago.The meter memory was reviewed for previous test result history: (b)(6).

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6202121
• Report Number: 1000113657-2016-02077
• Device Sequence Number: 13822460
• Product Code: NBW
• UDI-Device Identifier: 00087701426520
• UDI-Public: (01)00087701426520
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/28/2017
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MT1564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2016
• Supplement Report FDA Received Date: 12/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY